MAUDE Adverse Event Report: ZEPHYR ENDOBRONCHIAL VALVE (EBV)

ZEPHYR ENDOBRONCHIAL VALVE (EBV)

Model Number	ZEPHYR 4.0-J EDC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, a piece of the small sizing wing was visible inside the patient through the bronchoscope.

Search Alerts/Recalls

1 Device was Involved in the Event
Brand Name	ZEPHYR ENDOBRONCHIAL VALVE (EBV)
Common Device Name	ENDOBRONCHIAL VALVE
MDR Report Key	12694024
Report Number	3007797756-2021-00301
Device Sequence Number	4103564
Product Code	NJK
UDI-Device Identifier	00811907030621
UDI-Public	(01)00811907030621(10)505145V50(17)220813
Combination Product (Y/N)	N
Initial Reporter State	CA
Initial Reporter Country	US
PMA/510(K) Number	P180002
Number of Events Summarized	1
Summary Report (Y/N)	N
Serviced by Third Party (Y/N)	N
Reporter Type	Manufacturer
Report Source	company representative,health
Initial Reporter Occupation	Non-Healthcare Professional
Type of Report	Initial
Report Date (Section B)	10/25/2021
1 Patient was Involved in the Event
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Operator of Device	Health Professional
Device Expiration Date	08/13/2022
Device Model Number	ZEPHYR 4.0-J EDC
Device Catalogue Number	EDC-TS-4.0-J
Device Lot Number	505145-V5.0
Was Device Available for Evaluation?	No
Type of Report(Section G)	Thirty-Day
Initial Date Received by Manufacturer	09/27/2021
Initial Report FDA Received Date	10/25/2021
Was Device Evaluated by Manufacturer? (Y/N)	Device Not Returned to Manufacturer
Date Device Manufactured	08/13/2020
Is the Device Labeled for Single Use? (Y/N)	Yes
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N)	No
Usage of Device	Initial
Patient Sequence Number	1
Outcome Attributed to Adverse Event	Required Intervention;